Kornimate/medical-research-clean huggingface dataset:
diagnostic relevance of laser confocal microscopy for the screening of upper urinary tract tumors

Conditions: Hematuria; Nephrolithiasis; Cancer of Urinary Tract; Ureteropelvic Junction Obstruction

Summary: upper urinary tract tumors have an incidence of 1 to 2 cases for 100 000 persons per year. the standard treatment for these tumors is the ablation of the kidney, ureter and a part of the bladder surrounding the ureteral orifice. the development of new diagnosis and treatment techniques through natural routes opens the possibility to use conservative treatments. the investigators hypothesis is that during a reno-ureteroscopy, laser confocal microscopy will allow the discrimination between normal and pathologic urothelium by microscopic analysis. this will prevent the systematic use of biopsies which are often difficult and iatrogenic.

the objective of the present study is to assess contribution of laser confocal microscopy in diagnosing of upper urinary tract tumors during a reno-uteroscopy compared to analysing of architectural elements (vascular characteristics, organization) and cellular (morphology, cohesion, border).

Eligibility criteria:
inclusion criteria: * any legally adult fully informed patient who consent to participate to the study * patient followed by the urology department * indication for a diagnosis or treatment reno-ureteroscopy * coverage of the social insurance exclusion criteria: * minor patient * pregnancy or breast feeding * concomitant treatment (for example beta-blocker) * contra-indication to general anaesthesia * hypersensitivity to sodium fluorescein * medical history of cardio-pulmonary disease (myocardial infarction, cardiovascular event, bronchospasm ...) due to fluorescein instillation * medical history of asthma or allergy due to fluorescein instillation

Keywords: laser confocal microscopy superior urinary tract tumors
du-176b phase 2 dose finding study in subjects with non-valvular atrial fibrillation

Conditions: Atrial Fibrillation; Stroke

Summary: this study will be conducted in male and female subjects aged 18 to 80 years, inclusive, with non-valvular af and a chads2 score of at least 1. subjects will be treated on an outpatient basis. the subjects will be allocated randomly to the open-label warfarin or any double-blind du-176b dosages. du-176b will be administered orally for 12 weeks at two fixed doses. warfarin will be used as active control. warfarin dosing will be managed and monitored by the investigator with the dose adjusted to achieve an inr of 2.0 to 3.0, inclusive. the primary endpoints are incidence of major, clinically relevant non-major and minor bleeding events (all bleeding).


Eligibility criteria:
inclusion criteria: * male or female subjects 18 to 80 years of age * non-valvular af supported by abnormal ecg documented for two times (interval of more than 1 week) within 6 months prior to randomization. * chads2 score of at least 1. exclusion criteria: * subjects with mitral valve disease * subjects with previous valvular heart surgery * contraindication for anticoagulants * conditions associated with high risk of bleeding * acute coronary syndromes (acs), percutaneous coronary intervention (pci), mi, stroke, transient ischemic attack (tia) or coronary artery/cardiac/other major surgery within the previous 30 days * active infective endocarditis or life-expectancy \< 12 months
total parenteral nutrition associated cholestasis (tpnac) and plasma amino acid levels in neonates

Conditions: Premature Birth

Summary: the purpose of this study is to analyze if the infants who received primene solution, have lower serum levels of methionine and cysteine and higher serum levels of taurine, we also analyze if the infants who received primene solution develop tpn-associated cholestasis in a smaller proportion than those who received trophamine solution.

total parenteral nutrition is an essential component of the care of premature and ill infants. prolonged parenteral nutrition is associated with complications affecting the hepatobiliary system, such as cholelithiasis, cholestasis, and steatosis. the most common of these is total parenteral nutrition-associated cholestasis (tpnac), that occurs because of reduced bile flow from the liver into the duodenum. cholestasis causes liver damage and in some cases, death. infant and neonate are at particular risk for this complication. the incidence of tpnac ranges from 7.4 to 84%. animal studies have implicated amino acids in the production of cholestasis; whereas studies in human neonates suggest a direct effect of amino acid infusions on the hepatocyte canalicular membrane. an appropriate amino acid solution might compensate for the metabolic immaturity of infants and perhaps reduce total parenteral nutrition associated complications such as cholestasis. therefore, is important to compare the frequency of cholestasis and blood amino acid concentration during primene and trophamine use.

Eligibility criteria:
inclusion criteria: * newborns greater than 1500 g who enter the intensive care unit and their pathology requiring total parenteral nutritional support (necrotizing enterocolitis, intestinal atresia, short bowel syndrome). * gestational age greater than 30 weeks * patients with normal liver function tests for their age, prior to the initiation of total parenteral nutrition. * authorization from both parents or legal guardian for recruiting of the child into the study with consent signed form after the purpose and procedures have been explained exclusion criteria: * patients with acute renal failure * congenital liver disease, end-stage liver disease * patients with liver damage secondary to viral or bacterial infection * patients with liver damage secondary to drugs

Keywords: cholestasis tpn neonates primene trophamine methionine cysteine taurine total parenteral nutrition
epidemiology and clinical course of pulmonary embolism during and after hospitalisation

Conditions: Pulmonary Embolism

Summary: this survey will allow to identify pe prognostic, but also long-term complications, i.e. recurrence rate, on-treatment bleedings, deep-vein thrombosis sequella, pulmonary hypertension rate, and chronic pulmonary disease rate without ph. this database should help us identify risk-factors for each event.


Eligibility criteria:
inclusion criteria: * all pulmonary embolisms hospitalised in nice hospital. * acceptation to enter in the cohorte survey exclusion criteria: -
effects of intermittent exercise training programs in patients with myocardial infarction

Conditions: Myocardial Infarction

Summary: cardiovascular diseases are a leading cause of death worldwide. according to the world health organization (who), cardiovascular diseases constitute 1/3 of all causes of death. myocardial infarction (mi) is an irreversible myocardial necrosis due to prolonged ischemia. patients with mi are candidates for cardiac rehabilitation (cr). american heart association (aha) guidelines recommend exercise-based cardiac rehabilitation and suggest exercise to add to patients' routine treatment. when the literature on patients with mi is examined, various exercise programs are seen. the aims of present study is investigating and comparing the effectiveness of intermittent exercise training and aerobic exercise training programs in patients with mi.

cases are divided into two groups as exercise (control) and control group by closed envelope randomization method. all patients are informed about risk factors and risk factor management. all patients are trained 3 days in the first week under the supervision of a physiotherapist to learn individual exercise programs. exercise programs including warm-up, loading, cooling, and relaxation exercises are shown. the warm-up period is consist of light-paced walking, active movements of several large muscle groups. during the loading period, taking into consideration the heart rate, fatigue and shortness of breath, exercises such as walking, squat, limb movements with weights, stepping on the steps, walking on different floors are shown. stretching exercises are done during the cooling period. intermittent loading workouts will consist of 3-minute loads and 1-minute rest intervals. moderate aerobic exercise is consist of brisk walking to reach 60-85% of the person's maximum heart rate. participants of the experimental group are contacted every two weeks via communication methods such as e-mail, message and telephone conversation. exercise diary is given to all patients and is taken from them at the end of the study.

Eligibility criteria:
inclusion criteria: * having had mi at least 3 months ago * stable clinical status for at least two weeks * walking independently * volunteer for research study exclusion criteria: * having unstable angina * having uncontrolled hypertension * having hemodynamic instability * participating in any exercise program in the last six months * having a major orthopedic or neurological problem that limits functionality

Keywords: aerobic exercise intermittent exercise
operative time during the use of the synthetic glue ifabondtm in laparoscopic sacrocolpopexy

Conditions: Prolapse

Summary: laparoscopic sacrocolpopexy has now become the gold standard technique for correction of anterior and apical prolapse. in order to provide an alternative to stapling system and sutures involving vaginal erosion and shrinkage phenomena, there is a technique to fix material meshes by the use of a liquid, tissue, synthetic adhesive and sterile. the investigator hypothesizes that the use of ifabond ™ adhesive in laparoscopic sacrocolpopexy significantly reduces the time of surgery compared to the classic suture technique. the prospective, randomized, multicenter study therefore aims to compare the time of surgery when using the ifabond™ synthetic adhesive and the technique by sutures to fix material meshes in laparoscopic sacrocolpopexy.


Eligibility criteria:
inclusion criteria: * woman aged 18 years or more * stage iii or iv medial and/or anterior genital prolapse on the pelvic organ prolapse quantification (pop-q) classification (hysterocele and/or cystocele) requiring surgical correction * patient requesting surgery for the trouble caused by the prolapse exclusion criteria: * prolapse of pop-q stage \<iii or without functional impact * unacceptable postoperative risk disclosed on interview: coagulation disorder, immune disorder, evolutive disease, etc. * impaired lower-limb range of motion preventing positioning for surgery * pregnancy or intended pregnancy during study period * evolutive or latent infection or signs of tissue necrosis on clinical examination * non-controlled diabetes (glycated haemoglobin \>8%) * treatment impacting immune response (immunomodulators), ongoing or within previous month * history of pelvic region radiation therapy, at any time * history of pelvic cancer * non-controlled evolutive spinal pathology * known hypersensitivity to one of the implant components (polypropylene) * cyanoacrylate hypersensitivity * formaldehyde hypersensitivity * inability to understand information provided * no national health insurance cover; prisoner, or ward of court

Keywords: laparoscopic surgery synthetic glue ifabondtm time of surgery
retroperıtoneal soft-tıssue sarcomas

Conditions: Retroperitoneal Sarcoma; Margin, Tumor-Free

Summary: : soft tissue sarcomas are rare mesenchymal tumors with many subtypes. clean margin-wide resection is recommended for treatment. the guidelines recommend that sarcoma treatments be carried out in sarcoma centers. in this study, the location, histopathological features, clinical and demographic features, recurrence, and prognosis of retroperitoneal sarcomas were investigated.

the demographic, histopathological, and immunohistochemical data of the patients who were operated on with the diagnosis of intraabdominal mass at istanbul medeniyet university göztepe prof. dr. süleyman yalçın city hospital from march 2016 to december 2020 were retrospectively evaluated. ethical approval was obtained from istanbul medeniyet university göztepe prof. dr. süleyman yalçın city hospital ethics committee. patients diagnosed with pathological sarcoma subclass were included in the study. patients younger than 18 years were excluded from the study. visceral organ-origin sarcomas and extremity sarcomas were also excluded from the study. gist's were included in sarcoma subtypes by who in 2013. however, they were not included in the study due to their solid organ origin. the data of 18 patients' whore remained after the exclusion criteria were analyzed retrospectively. pathology samples of the patients were re-examined by a single pathologist. the demographic analysis was used for statistics.

Eligibility criteria:
inclusion criteria: * patients operated with the diagnosis of intra-abdominal mass * patients diagnosed with pathological sarcoma subclasses exclusion criteria: * patients younger than 18 years * visceral organ-origin sarcomas * extremity sarcomas * gist

Keywords: soft tissue sarcoma surgery multidisciplinary sarcoma team
hypothermia to prevent high intracranial pressure in patients with acute liver failure

Conditions: Acute Liver Failure; Intracranial Hypertension

Summary: treatment options in patients with high intracranial pressure due to acute liver failure are limited. this study intends to evaluate the effect of prophylactic hypothermia on preventing high intracranial pressure and compromised cerebral oxidative metabolism.

acute liver failure (alf) is associated with a high mortality. with severe hepatic encephalopathy and elevated arterial ammonia concentration (\< 200 micromol/l) more than 50% of the patients will develop high intracranial pressure (icp) and risk cerebral incarceration and death. the therapeutic options are limited in treating and preventing this condition and new interventions are much sought after. as in hypothermia used for patients after cardiac resuscitation it could be speculated that hypothermia and the reduced cerebral metabolic rate would contribute to neuroprotection and reduce the risk of cerebral hypertension in patients with alf. we have designed this open, randomized and unblinded study in order to evaluate the effect of prophylactic hypothermia on icp, cerebral hemodynamics and oxidative metabolism. patients are randomized to standard medical treatment (smt) or smt and hypothermia 33° c for 72 hours using a cooling mattress (blanketrol ii, cincinnati sub-zero). all patients will receive mechanical ventilation, antibiotics, inotropic support and monitored with invasive and non-invasive equipment in accordance to local guidelines. in copenhagen monitoring cerebral hemodynamics includes: placement of a intracranial pressure measuring catheter (camino (r), integra) for monitoring icp. furthermore, a microdialysis catheter (cma-70) placed in brain cortex is used for monitoring brain metabolism. finally, cerebral perfusion can be monitored by measuring mean flow velocity using transcranial doppler and/or oxygen saturation in blood from the jugular vein. ethical considerations: the helsinki ii declaration will be followed and informed consent is mandatory for enrollment. in any patient where hypothermia is believed or suspected to be harmful the study should be stopped and the primary investigator should be notified immediately. all adverse effects will be recorded and published together with the full paper.

Eligibility criteria:
inclusion criteria: * acute liver failure * and hepatic encephalopathy stage 3 or 4 * and informed and written consent by closest relative(s) * and arterial ammonia concentration above 150 micromol/l or clinical suspicion of cerebral edema * and an icp-measuring device exclusion criteria: * no or withdrawn informed consent * pregnant or breast feeding women * uncontrollable infection * hemodynamically instable patients * active bleeding
alnd vs art in positive sentinel node after neoadjuvant therapy in breast cancer

Conditions: Breast Cancer; Chemotherapy; Sentinel Lymph Node; Axillary Lymph Nodes Dissection; Radiotherapy Side Effect

Summary: in the case of primary surgery, in patients with sentinel node involvement, it has already been shown that omitting axillary lymph node dissection (alnd), often combining axillary radiotherapy (rt), does not worsen the prognosis and does significantly reduce the appearance of lymphedema. however, patients who have received neoadjuvant systemic treatment cannot benefit from this option, even though in the majority of those who have responded well to treatment, a residual disease in the armpit is low, but there are no studies yet published that supports the possibility of not performing lymphadenectomy. the primary endpoint is to evaluate wether axillary radiotherapy (art) presents a lower risk of lymphedema with respect to lymphadenectomy (alnd) in patients with breast cancer who, after neoadjuvant systemic treatment (nst), present the sentinel node affected. likewise, we will evaluate recurrences and overall survival in both groups. finally, we will analyze the quality of life of these patients.

a prospective, randomized, open-label, parallel-assigned, multicenter study. the estimated sample size is 1660 patients, over 5 years. patients will be stratified and analyzed independently according to the neoadjuvant treatment regimen, whether chemotherapy (ct) +/- hormonal therapy (ht). a pilot phase of the study was carried out with the first 200 patients. an interim analysis will also be performed with the first 820 patients recruited.

Eligibility criteria:
inclusion criteria: * t1-t4 n0/ t0-t4 n1 at diagnosis and subsidiary of neoadjuvant treatment * post-ct sln with ≤2 macrometastasis/micrometastasis or itcs * post-ct axillary response by ultrasound or mri * complete at least 70% of neoadjuvant chemotherapy and 6 months of endocrine treatment. exclusion criteria: * cn2 * ypn0 * history of breast surgery for ipsilateral cancer in the last 10 years * history of other cancer in the last 5 years, except squamous carcinoma of the skin.
multidisciplinary approach to fatigue

Conditions: Breast Cancer; Germ Cell Tumor

Summary: prospective longitudinal, single-center, non-randomized study for the implementation of an integrated multidisciplinary fatigue follow-up for young patients with breast cancer or germ cell tumour

each patient will receive a full evaluation by a multidisciplinary evaluation by a multidisciplinary team during one day. this evaluation will take place between 1 and 3 months after the end of "acute" treatments. the team is composed of an oncologist, a psychologist, a physiotherapist, a dietician and a nurse-coach. the goal of this comprehensive evaluation is to : * to detect organic or psychological factors (severe depression,...) contributing to fatigue. * to evaluate in detail the impact of fatigue on the patient's daily life. * to evaluate the patient's level of physical activity in order to propose an adequate and and personalized management. during this evaluation, the patient will be asked to discuss which aspects of his or her daily life he or she would like to improve as a priority. at the end of this complete evaluation, each patient's case will be will be discussed in a multidisciplinary meeting with all the people involved in the program in order to propose a detailed and personalized treatment plan. this plan will be explained in detail to the patient by the nurse-coach who will organize and coordinate the patient's care. the patient will receive the detailed management plan in writing. the patient will receive the detailed management plan in writing, which will also be communicated to the patient's treating physicians.

Eligibility criteria:
inclusion criteria: * age between 18 and 39 years at the time of signing the informed consent * patient who speaks and understands french * signed study informed consent form obtained prior to any study related procedures * at minimum, a moderate (\>3) fatigue level according to the standard rating scale (nrs) 1 month after completion of acute treatment; as measured at the survivorship of the standard program * patient with either: curative breast cancer (ajcc stage i-ii-iii) or a germ cell tumor exclusion criteria: * refusal to participate in the study * patient having chosen to participate in another psychosocial intervention study for the duration of the study. * patients with ajcc stage iv breast cancer
nasal nitric oxide levels in eosinophilic esophagitis (eoe)

Conditions: Eosinophilic Esophagitis

Summary: this study is aimed at understanding whether oral nitric oxide levels can be used as a non-invasive marker for the diagnosis and management of patient with eosinophilic esophagitis (eoe).

nitric oxide (no) is produced by activated eosinophils and oral no levels are known to be elevated in asthma and eosinophilic bronchitis. the measurement of oral no is a non-invasive,easy to perform low cost procedure that is used frequently in the diagnosis and management of asthma. the diagnosis of eosinophilic esophagitis (eoe) requires conscious sedation, an upper endoscopy with biopsy, and histologic evaluation of the biopsy specimen. this is a costly and somewhat invasive procedure. if oral no was elevated as a result of activity of esophageal eosinophils in eoe, the measurement of oral no may potentially be a very convenient and useful test in the evaluation and treatment of eoe. we propose a pilot study to determine if oral no levels are elevated in patients with eosinophilic esophagitis.

Eligibility criteria:
inclusion criteria: * subjects with dysphagia and active esophageal infiltration (esophageal eosinophilic count of \>/= 15 eos/hpf) * subjects with or without a clinical diagnosis of asthma exclusion criteria: * subjects with chronic cough * severe cad * mi within the last 3 months * cystic fibrosis * tuberculosis * chronic obstructive pulmonary disease (copd)

Keywords: dysphagia, trouble swallowing, chest pain
a 12-week extension of the phase iii study (d3820c00004) to assess the effect and safety of nktr-118 in patients with non-cancer-related pain and opioid-induced constipation

Conditions: Opioid-Induced Constipation (OIC)

Summary: the purpose of this study is to evaluate the effect and safety of nktr-118 treatment of opioid-induced constipation in patients with non-cancer-related pain over a 6-month period.


Eligibility criteria:
inclusion criteria: * must have completed the 12-week study d3820c00004 through visit 8. * provision of written informed consent prior to any study-specific procedures. * men and women who were between the ages of \>18 and \<85 years at the time of the screening visit for study d3820c00004. * continuing to receive a stable maintenance opioid regimen consisting of a total daily dose of 30 mg to 1000 mg of oral morphine, or equianalgesic amount(s) of 1 or more other opioid therapies. * willingness to continue abstinence from all laxatives and other bowel regimens including prune juice and herbal products throughout this additional 12-week treatment period, and to use only bisacodyl as rescue medication if a bowel movement (bm) has not occurred within at least 72 hours of the last recorded bm. exclusion criteria: * patients receiving opioid regimen for treatment of pain related to cancer. * history of cancer within 5 years from the screening visit of study d3820c00004 with the exception of basal cell cancer and squamous cell skin cancer. * medical conditions and treatments associated with diarrhea, intermittent loose stools, or constipation. * other issues related to the gastrointestinal tract that could impose risk to the patient. * pregnancy or lactation.

Keywords: non-cancer-related pain opioid-induced constipation.